REACTOGENICITY OF A HEXAVALENT
DTPa-HBV-IPV/Hib VACCINE GIVEN AS PRIMARY VACCINATION
Aristegui J1,
Diez-Delgado J2, Mares J3, Casanovas JM4,
De Frutos E5, Van Esso D6, Verdaguer J7,
De la Flor J8, Moraga F9, Boceta R10,
Garcia-Martinez JA10, Garcia-Corbeira P10,
Dal-Re R10
1Basurto Hosp.(Bilbao); 2Torrecardenas
Hosp.(Almer¨ªa); 3Int. Ped. Mares-Riera (Girona); 4CAP
Roquetes; 5CAP Canovelles; 6CAP Serraparera; 7CAP
Sant Llatzer; 8CAP Sant Vicenç dels Horts; 9Vall
d¡¯Hebron Hosp.(Barcelona); 10 GSK (Madrid), Spain
Objective: To compare the reactogenicity of a single injection
of DTPa-HBV-IPV/Hib combined vaccine with separate injections of
DTPa-IPV/Hib and hepatitis B vaccines.
Methods: In an open randomised study conducted in Spain,
infants received either 1 injection of DTPa-HBV-IPV mixed with Hib in the
same syringe (InfanrixTM Hexa) or 2 separate injections of
DTPa-IPV/Hib (InfanrixTM-IPV/Hib) and hepatitis B (EngerixTM-B)
as a primary vaccination course at 2, 4 and 6 months. Study vaccines were
manufactured by GlaxoSmithKline Biologicals.
Results: Incidence of local and general adverse reactions (ARs)
during a 4-day follow-up period after all doses (705 diary cards returned).
|
AR % all doses (95%CI)
|
DTPa-HBV-IPV/Hib
(N = 360)
|
DTPa-IPV/Hib + Hepatitis B
(N = 345)
|
|
Pain *
|
2.5 (1.2-4.7)
|
1.2 (0.3-2.9)
|
|
Redness > 20 mm
|
1.1 (0.3-2.8)
|
0.3 (0.0-1.6)
|
|
Swelling > 20 mm
|
1.4 (0.5-3.2)
|
0.9 (0.2-2.5)
|
|
Fever ** > 39.5¡ãC
|
0.0 (0.0-1.0)
|
0.3 (0.0-1.6)
|
|
Fussiness ***
|
2.8 (1.3-5.0)
|
2.0 (0.8-4.1)
|
* child cries when limb
was moved ** rectal ***interfering normal daily
activities
Conclusion: DTPa-HBV-IPV/Hib vaccine has a
similar reactogenicity profile to that of DTPa-IPV/Hib + hepatitis B
vaccines .